BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K251019 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Bioteq I.V. (Intravenous) Set

  Class II

  FDA 510(k) K002449 Active Cleared 22 Dec 2000

• Bioteque A.V. Fistula Needle Set

  Class II

  FDA 510(k) K993118 Active Cleared 17 Dec 1999

• Sheath Introducer

  Class II

  FDA 510(k) K150932 Active Cleared 22 Jul 2016

• Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock

  Class II

  FDA 510(k) K033862 Active Cleared 14 Feb 2005

• Bioteque Hemodialysis Blood Tubing Set

  Class II

  FDA 510(k) K992930 Active Cleared 9 Feb 2000

• BIOTEQ Drainage Catheter BT-PDS-series

  Class II

  FDA 510(k) K210419 Active Cleared 13 Apr 2022

See all devices from Bioteque Corp. →

• What clinical specialties are the Bioteq Drainage Catheter Sets primarily used in, and why are they relevant for those fields?

  The Bioteq Drainage Catheter Sets (BT-PD1-Series-G and BT-PDS-Series-G) are designed for use in gastroenterology and urology, as indicated by their advisory committee classification (GU) and medical specialty description. These specialties rely on biliary drainage procedures to manage obstructions, post-surgical drainage, or fluid removal from the biliary system, making the catheter sets highly relevant for their procedural needs.

• Are these catheter sets reusable, or are they intended for single-use only? How does this affect their handling?

  The Bioteq Drainage Catheter Sets are explicitly labeled as sterile, single-use devices. This means each set is intended for one-time clinical use only, and proper disposal after use is required to prevent contamination and ensure patient safety. Single-use design also eliminates the need for reprocessing, simplifying workflow and reducing infection risks.

• Can these catheters be used in MRI environments, and what storage conditions should be followed to maintain their functionality?

  Yes, the Bioteq Drainage Catheter Sets are non-magnetic, making them compatible with MRI environments. However, to preserve sterility and functionality, they must be stored in sealed packaging at room temperature as specified by the manufacturer. Avoid exposing them to extreme temperatures or moisture, which could compromise their integrity.

• What regulatory pathways have these catheter sets followed, and what does this mean for their use in clinical settings?

  The Bioteq Drainage Catheter Sets have been authorized under FDA 510(k) and MDD (Medical Device Directive) frameworks, with a classification as Device Class II. This means they have undergone rigorous review to demonstrate substantial equivalence to predicate devices, ensuring they meet safety and performance standards for biliary drainage procedures. Clinicians can rely on their compliance with these regulatory requirements for clinical use.